MAUDE Adverse Event Report: RANIR, LLC REST ASSURED, GEN II ORIGINAL; MOUTH GUARD

Model Number REST ASSURED, GEN II ORIGINAL

Device Problems Detachment Of Device Component (1104); Material Disintegration (1177); Malposition of Device (2616)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Consumer stated he bought the guard months ago and is finally using it.The instructions were clear and he has fitted this type of guard before.He had to re-boil this one an extra time because the initial fit cooled before he got a good impression.Upon the 2nd attempt, the front part of the hard material disintegrated, but the impression was ok.He had to trim back the ends multiple time due to very sharp corners that dug in while he slept.After about 2 weeks the soft material started to detach from the hard material.

Manufacturer Narrative

Consumer stated he bought the guard months ago and is finally using it.The instructions were clear and he has fitted this type of guard before.He had to re-boil this one an extra time because the initial fit cooled before he got a good impression.Upon the 2nd attempt, the front part of the hard material disintegrated, but the impression was ok.He had to trim back the ends multiple time due to very sharp corners that dug in while he slept.After about 2 weeks the soft material started to detach from the hard material.

• Brand Name: REST ASSURED, GEN II ORIGINAL
• Type of Device: MOUTH GUARD
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4343209
• MDR Text Key: 5200734
• Report Number: 1825660-2014-00980
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: REST ASSURED, GEN II ORIGINAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1